Details for New Drug Application (NDA): 211045
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NDA 211045 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.
The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 211045
| Tradename: | DARIFENACIN HYDROBROMIDE |
| Applicant: | Polygen Pharms |
| Ingredient: | darifenacin hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 211045
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 211045
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 211045 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-067 | 52605-067-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10) |
| DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 211045 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-067 | 52605-067-19 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 7.5MG BASE | ||||
| Approval Date: | Jan 6, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Jan 6, 2020 | TE: | AB | RLD: | No | ||||
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